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Evaluating the performance of four anti-dsDNA antibody detection methods
Xuedan Gao1,2,3, Liqiong Wu4, Yi Li1,2,3
1Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, China.
Lupus
|August 23, 2025
Summary
Four methods for detecting anti-dsDNA antibodies, including Crithidia luciliae indirect immunofluorescence test (CLIFT) and digital liquid chip method (DLCM), show high diagnostic efficacy for systemic lupus erythematosus (SLE). DLCM offers the highest sensitivity, while CLIA has the highest specificity.
Area of Science:
- Immunology
- Clinical Chemistry
- Autoimmune Diseases
Background:
- Anti-double-stranded DNA (anti-dsDNA) antibodies are crucial biomarkers for diagnosing and monitoring systemic lupus erythematosus (SLE).
- Accurate detection of anti-dsDNA antibodies is essential for effective SLE patient management.
- Evaluating the concordance and diagnostic performance of various detection methods is vital for clinical laboratory practice.
Purpose of the Study:
- To assess the concordance among four anti-dsDNA antibody detection methods: Crithidia luciliae indirect immunofluorescence test (CLIFT), enzyme-linked immunosorbent assay (ELISA), acridine ester direct chemiluminescence immunoassay (CLIA), and digital liquid chip method (DLCM).
- To evaluate the diagnostic efficacy of these methods in patients with SLE.
- To correlate antibody detection with SLE disease activity and specific complications like lupus nephritis.
Main Methods:
- Analysis of 285 serum samples, including 170 SLE patients, 39 with non-SLE autoimmune diseases, 28 with non-autoimmune diseases, and 48 undiagnosed cases.
- Comparison of CLIFT, ELISA, CLIA, and DLCM for anti-dsDNA antibody detection.
- Assessment of diagnostic performance (sensitivity, specificity, ROC curve analysis) and concordance (kappa statistics).
Main Results:
- Digital liquid chip method (DLCM) demonstrated the highest sensitivity (86.87%), while acridine ester direct chemiluminescence immunoassay (CLIA) showed the highest specificity (94.03%).
- The area under the receiver operating characteristic (ROC) curve was ranked: CLIFT < ELISA < CLIA < DLCM (AUC = 0.938).
- CLIFT and DLCM correlated well with SLE disease activity index (SLEDAI); CLIFT and CLIA correlated significantly with lupus nephritis. Overall concordance ranged from 80.14% to 91.29% depending on the method pairing.
Conclusions:
- All four methods (CLIFT, ELISA, CLIA, DLCM) exhibit significant diagnostic efficacy for anti-dsDNA antibodies.
- CLIFT shows a strong correlation with SLE disease activity and lupus nephritis.
- DLCM, a novel method, presents excellent performance and is suitable for integration into clinical laboratory workflows for anti-dsDNA antibody testing.
